Troubled Halol plant earns Sun a US FDA Form 483

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The US FDA has issued Sun Pharmaceutical Industries with a Form 483 citing problems identified at its plant in Halol.

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WHO commits to source drugs and vaccines from 'green' suppliers

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US drug reimportation 'Trump proposal' risky and inefficient, AmerisourceBergen

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Mylan says cost cutting plan will impact up to 10% of its staff

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Fareva opens aerosol plant as part of $40m drug and OTC business investment

Lonza's peptides facility in Braine-l’Alleud, Belgium (source Google maps)

Lonza to sell therapeutic peptides business to PolyPeptide

Interquim facility in Barcelona, Spain (source Google maps)

US FDA says Interquim's API plant remediation plan is inadequate

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GSK extends single-use purification tech R&D deal with Puridify

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Regulatory & Safety

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Takeda overturns negative EU CHMP opinion for oral drug Ninlaro in ‘face-to-face’ appeal

source SwissMedic

Indian-made fake erectile dysfunction meds seized in Switzerland en route from Serbia

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Bluebird Bio reports positive early safety data from Ph I CAR-T trial

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Ingredients

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Merck launches HME excipient with high API loading capacity

Italian PM Matteo Renzi (Source Wikipedia)

Italian PM's resignation will hit API sector if anti-EU party takes power says expert

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Ita-leave? Italian referendum may impact European API supply chain

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Drug Delivery

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Needle-free Zika vaccine shows promise in clinical trial

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AstraZeneca sets out on a $1bn 'Bicycle' path

David Lewis - CSO of Arrowhead

Arrowhead fires CSO & Co-inventor of delivery tech responsible for clinical trial abandonment

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Processing

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Takeda to build €40m Irish plant for global Ninlaro API supply

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Takeda building Dengue fever vaccine plant

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Spain's Idifarma adds capsule filling to service offerings

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Popular News

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Operator silence rings alarm bells during audits, say FDA and WHO experts

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US FDA finalises contract manufacturing quality agreement guidance

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ICH completes draft Q11 implementation Q&A; welcomes ANVISA and MFDS

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